US20230355943A1 - Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes - Google Patents
Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes Download PDFInfo
- Publication number
- US20230355943A1 US20230355943A1 US18/143,318 US202318143318A US2023355943A1 US 20230355943 A1 US20230355943 A1 US 20230355943A1 US 202318143318 A US202318143318 A US 202318143318A US 2023355943 A1 US2023355943 A1 US 2023355943A1
- Authority
- US
- United States
- Prior art keywords
- catheter
- access port
- near patient
- patient access
- adapter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000523 sample Substances 0.000 title claims abstract description 25
- 230000006641 stabilisation Effects 0.000 title claims abstract description 17
- 238000011105 stabilization Methods 0.000 title claims abstract description 17
- 239000008280 blood Substances 0.000 title description 18
- 210000004369 blood Anatomy 0.000 title description 18
- 238000001802 infusion Methods 0.000 title description 4
- 238000003780 insertion Methods 0.000 claims abstract description 39
- 230000037431 insertion Effects 0.000 claims abstract description 39
- 230000002093 peripheral effect Effects 0.000 claims abstract description 16
- 210000005166 vasculature Anatomy 0.000 claims abstract description 14
- 230000000087 stabilizing effect Effects 0.000 claims description 16
- 238000002347 injection Methods 0.000 claims description 14
- 239000007924 injection Substances 0.000 claims description 14
- 230000002792 vascular Effects 0.000 description 8
- 230000000845 anti-microbial effect Effects 0.000 description 7
- 238000005259 measurement Methods 0.000 description 7
- 239000004599 antimicrobial Substances 0.000 description 6
- 210000003462 vein Anatomy 0.000 description 6
- 230000008901 benefit Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- -1 wires Substances 0.000 description 2
- 208000032840 Catheter-Related Infections Diseases 0.000 description 1
- 206010059484 Haemodilution Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 210000001099 axilla Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229940039231 contrast media Drugs 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000002637 fluid replacement therapy Methods 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000003966 vascular damage Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0637—Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M2039/0202—Access sites for taking samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M2039/0205—Access sites for injecting media
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/027—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
Definitions
- the present disclosure generally relates to integrated midline catheter systems. More particularly, the integrated midline catheter systems may include catheter adapter stabilization and a near patient access port configured for blood draw, infusion, and/or insertion of digital probes into the patient's vasculature via the indwelling midline catheter.
- Midline catheters are generally used for parenteral nutrition, IV fluid replacement, and/or the administration of analgesics and antibiotics.
- Midline catheters are inserted at the bedside using sterile techniques and can remain in place for several weeks. The insertion (venipuncture) is performed above and below the antecubital fossa in the cephalic, basilica, or bronchial veins.
- the catheter may be of various lengths and gauges, with the tip of the catheter terminating below the axilla and proximal central veins.
- midline catheters The potential advantages of a midline catheter are the reduced frequency of repeated venipunctures for labs/restarts, decreased incidence of catheter related infections, extended implant/indwell duration, improved clinical outcomes, patient satisfaction and associated cost savings. Placing the catheter tip in the larger diameter veins of the upper arm compared to smaller veins provides for improvements in drug delivery therapy and hemodilution. Midline catheters can also be used for infusing contrast media at higher flow rates that are typically done by other catheters such as, e.g., peripheral intravenous catheters (PIVCs).
- PIVCs peripheral intravenous catheters
- vascular access devices such as PIVCs over midline catheters
- a blood draw device known as PIVOTM from Becton, Dickinson and Company
- PIVOTM is configured as a single-use device which temporarily attaches to a PIVC to draw a blood sample.
- the PIVOTM device advances a flexible, internal probe or flow tube through the PIVC to (or beyond) the catheter tip to collect a blood sample.
- This flow tube is designed to extend beyond the suboptimal draw conditions around the indwelling line to reach vein locations where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted, and the device is removed from the PIVC and discarded.
- An example of one such blood draw device is shown and described in U.S. Pat. No. 10,300,247 B2, which is incorporated by reference herein in its entirety.
- devices configured direct probes, wires, fibers, guidewires, sensors, etc. through the PIVC and into the patient's vasculature for in-vein digital measurements have also been developed.
- conventional midline catheter systems lack the access architecture needed for compatibility with such blood draw and/or in-vein digital measurement devices.
- the present disclosure generally relates to an integrated midline catheter system.
- the system includes a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter.
- the system also includes a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port includes a connector portion couplable to a peripheral probe device.
- the system further includes a catheter insertion device, wherein the catheter insertion device is configured to enable distal movement of the catheter adapter and catheter so as to position the catheter within a patient's vasculature.
- the near patient access port further includes a secondary port, and the secondary port is coupled to an integrated extension set.
- system further includes a proximal access port coupled to a proximal end portion of the integrated extension set.
- the proximal access port is color-coded to provide a flow rate indication.
- the proximal access port comprises indicia indicative of at least one of catheter length and catheter gauge.
- the connector portion of the near patient access port is a needle-free connector.
- the needle-free connector is a split septum needle-free connector.
- the near patient access port further includes a high-pressure injection port.
- the high-pressure injection port is color-coded to provide a flow rate indication.
- the high-pressure injection port includes indicia indicative of at least one of catheter length and catheter gauge.
- the stabilization platform includes a pair of stabilizing wings.
- each of the stabilizing wings includes a gripping surface to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
- the system includes a pair of catheter advancement tabs extending from the catheter adapter and configured to provide to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
- the catheter advancement tabs are detachable from the catheter adapter.
- the catheter insertion device further includes a housing, an introducer needle extending distally from the housing, and an actuator tab slidable along the housing to selectively advance a guidewire through the introducer needle, wherein the catheter is configured to selectively advance over the introducer needle and the guidewire.
- the catheter insertion device is detachable from the catheter adapter after insertion of the catheter within the patient's vasculature.
- an integrated midline catheter system includes a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter.
- the system also includes a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port comprises a connector portion couplable to a peripheral probe device.
- the catheter is between 8 cm and 10 cm in length.
- the near patient access port further includes a secondary port, and the secondary port is coupled to an integrated extension set.
- the connector portion of the near patient access port is a needle-free connector.
- FIG. 1 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with an aspect of the present disclosure
- FIG. 2 is an isometric view of the integrated midline catheter, stabilization, and near patient access port of FIG. 1 ;
- FIG. 3 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure
- FIG. 4 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure.
- FIG. 5 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure.
- the distal end of a component or of a device means the end furthest away from the hand of the user and the proximal end means the end closest to the hand of the user, when the component or device is in the use position, i.e., when the user is holding a catheter insertion device in preparation for or during use.
- the terms “in the distal direction” and “distally” mean in the direction toward distal tip of the needle or catheter of the system
- the terms “in the proximal direction” and “proximally” mean in the direction opposite the direction of the distal tip of the needle or catheter.
- Embodiments of the present disclosure will primarily be described in the context of devices for use with integrated midline catheters. However, embodiments of the present disclosure equally extend to use with other catheter devices.
- the system 10 includes a catheter insertion device 11 having a housing 12 .
- An introducer needle 14 extends from a distal end of the housing 12 , with the introducer needle 14 having a distal tip 15 .
- a distal end portion of the housing 12 may include a feature or surface to at least partially support an intermediate portion of the introducer needle 14 during insertion, thereby reducing the flexibility of the introducer needle 14 during insertion.
- An actuator tab 16 is positioned on a surface of the housing 12 , with the actuator tab 16 configured for substantially linear movement along a slot 17 formed in the housing 12 . While not shown in FIG. 1 , the actuator tab 16 may be operably coupled to a guidewire, with the guidewire being sized and configured to selectively pass through (and beyond) the introducer needle 14 as actuator tab 16 is advanced distally along the slot 17 and, conversely, to retract through the introducer needle 14 when the actuator tab 16 is retracted proximally by the clinician.
- the guidewire may include a blunt, atraumatic tip to substantially prevent vascular damage. In some embodiments, a polymer rod or tubing with an atraumatic tip may replace the guidewire.
- system 10 further includes a catheter adapter 18 having a stabilization platform formed of opposing stabilizing wings 20 A, 20 B.
- the catheter adapter 18 is disposed at least partially within the housing 12 such that the stabilizing wings 20 A, 20 B extend externally from opposing lateral sides of the housing 12 .
- the catheter adapter 18 is configured to move linearly along the housing 12 in a distal direction such that a catheter 21 (shown in FIG. 2 ) may be selectively advanced over the introducer needle 14 and into the patient's vasculature.
- the catheter 21 may be any appropriate length and gauge for use as a midline catheter.
- catheter 21 may have a length between 8 cm and 10 cm, and may be one of 16 GA, 18 GA, 20 GA, or 22 GA. However, it is to be understood that catheter 21 is not limited to the above-referenced lengths and/or gauges. Additionally, the catheter 21 may be formed of any appropriate material such as, e.g., polyurethane. The catheter 21 may have a reinforced tip 25 , which may be configured to substantially prevent the catheter tip from collapsing and/or aid in deployment and positioning of the catheter 21 .
- the clinician identifies the appropriate insertion site, and cleans and prepares the insertion site in accordance with institutional policy.
- the clinician then grips and advances the entire catheter insertion device 11 to insert the introducer needle 14 into an appropriate vein or other vascular access location of the patient.
- the system may include magnetic needle guidance to ensure proper insertion of the introducer needle 14 .
- the magnetic needle guidance may be used in conjunction with ultrasound placement system and methods such as, e.g., the Cue Needle Tracking System from Becton, Dickinson and Co.
- the clinician may then advance the actuator tab 16 distally along the slot 17 such that a guidewire (now shown) operably coupled to the actuator tab 16 simultaneously advances through the introducer needle 14 , thereby providing an extended guided path for deployment of the catheter 21 .
- the clinician may distally advance the catheter adapter 18 along the housing 12 , thereby also advancing the catheter 21 over the introducer needle 14 and guidewire, moving the catheter 21 into a desired position within the patient's vasculature.
- the clinician may grip or otherwise manipulate one or both of the stabilizing wings 20 A, 20 B. Additionally and/or alternatively, the clinician may utilize a side branch 22 extending from the catheter adapter 18 to aid in advancement of the catheter adapter 18 and catheter 21 .
- the clinician may separate the catheter insertion device 11 from the catheter adapter 18 .
- the housing 12 of the catheter insertion device 11 may at least partially split after placement of the catheter 21 , allowing the housing 12 separate from the catheter adapter 18 .
- the introducer needle 14 and guidewire (not shown) are also withdrawn from the catheter 21 and are pulled through a self-sealing proximal connector portion 19 of the catheter adapter 18 .
- the catheter adapter 18 remains in place at the insertion site in the second configuration shown in FIG. 2 , with the stabilizing wings 20 A, 20 B configured to stabilize the catheter adapter 18 .
- a strain relief feature 23 may be provided between the catheter adapter 18 and the catheter 21 .
- the system 10 further includes a near patient access port 26 .
- Near patient access port 26 is configured to provide catheter access to peripheral devices such as, e.g., a blood draw device (e.g., PIVOTM from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements.
- peripheral devices such as, e.g., a blood draw device (e.g., PIVOTM from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements.
- the near patient access port 26 is coupled to the side branch 22 of catheter adapter 18 via a length of intermediate tubing 24 .
- it is to be understood that near patient access port 26 may be coupled directly to the side branch 22 , or connected via another intermediate member.
- Near patient access port 26 includes a connector portion 28 .
- connector portion 28 is configured to be compatible with peripheral devices such as blood draw devices and/or vascular access probes.
- the connector portion 28 may include an interface for secure coupling of the peripheral device(s) to the connector portion 28 .
- the connector portion 28 is configured as a needle-free connector (NFC) configured to receive, e.g., a blunt introducer of a blood draw device.
- NFC needle-free connector
- the connector portion 28 may be configured as a split-septum NFC with direct probe access such as, e.g., Q-SyteTM or SmartSiteTM NFCs from Becton, Dickinson and Co., or any other appropriate split-septum NFC.
- the connector portion 28 may be formed of a non-split-septum-type NFC.
- the near patient access port 26 may include anti-microbial and/or flush-promoting features.
- the near patient access port 26 may include one or more of an offset tubing port vortex-creating feature, a proximal flow-diverting feature, anti-microbial NFC lubricant, anti-microbial eluting surface coating(s) or insert(s), etc.
- the system 10 provides for probe (or tube) access from a peripheral probe device through the indwelling catheter 21 .
- catheter 21 is a midline catheter and is generally longer in length than, e.g., a PIVC
- the length probe or tube of the peripheral probe device may be altered and/or optimized for use with the midline catheter, thereby enabling the probe or tube to potentially extend beyond the reinforced tip 25 of the catheter 21 when deployed.
- Near patient access port 26 further includes a secondary port 30 positioned near a distal end thereof.
- the secondary port 30 is coupled to an integrated extension set 32 , with the integrated extension set 32 further being coupled to a proximal portion 36 at a proximal end thereof.
- a clamp 34 may be provided on the integrated extension set 32 , with the clamp 34 configured to selectively restrict flow through the integrated extension set 32 .
- the clamp 34 may be color-coded to signify the type and/or injection compatibility of the integrated extension set 32 .
- the proximal portion 36 may include a proximal access port 38 and a proximal connector 40 .
- the proximal connector 40 may be removably or non-removably coupled to the proximal access port 38 , and proximal connector 40 may be configured to allow fluid infusion through the catheter 21 via the near patient access port 26 .
- the proximal access port 38 may be color-coded and/or may contain indicia to indicate catheter length, catheter gauge, high-pressure injection compatibility, etc.
- the proximal connector 40 may be replaced with, e.g., a removable vent plug.
- the proximal access port 38 may be a non-split-septum connector, and may include antimicrobial and/or flush-ability features. While only a single proximal access port 38 is shown, it is to be understood that the proximal portion 36 may be configured to include more than one access port.
- the secondary port 30 of the near patient access port 26 is configured as an angled port, resulting in the near patient access port 26 being a y-shaped adapter.
- the secondary port 30 may be configured as a t-shaped adapter such that the secondary port 30 enters the near patient access port 26 at a substantially 90° angle.
- secondary port 30 is shown as being directed towards the center of the device, it is to be understood that secondary port 30 may be directed away from the device.
- the integrated midline catheter system 10 described above with respect to FIGS. 1 and 2 provides a midline catheter system with a near patient access port compatible with instrument, probe, and/or tubing delivery through the midline catheter and into the patient's vascular system, which conventional integrated midline catheter systems do not provide.
- System 50 includes many similar features as system 10 described above with respect to FIGS. 1 and 2 and, as such, like reference numerals are used throughout.
- the catheter insertion device 51 as shown in FIG. 3 includes a pair of catheter advancement tabs 52 A, 52 B extending from opposing sides of the housing 12 , with the catheter advancement tabs 52 A, 52 B being separate from the stabilizing wings 20 A, 20 B of the stabilization platform.
- the catheter advancement tabs 52 A, 52 B are operably coupled to the catheter adapter 18 (not shown in FIG. 3 ) so as to provide grips for the clinician to advance the catheter adapter 18 and catheter 21 distally along the housing 12 .
- the catheter advancement tabs 52 A, 52 B remain in place with the catheter adapter 18 .
- the catheter advancement tabs 52 A, 52 B may be separable and removable from the catheter adapter 18 after placement of the catheter.
- the catheter advancement tabs 52 A, 52 B may be color-coded according to the length and/or gauge of the catheter housed within the catheter insertion device 51 . Furthermore, while two catheter advancement tabs 52 A, 52 B are shown in FIG. 3 , it is to be understood that only one catheter advancement tab may be provided.
- system 60 includes many similar features as system 10 described above with respect to FIGS. 1 and 2 and, as such, like reference numerals are used throughout.
- system 50 which utilized separate catheter advancement tabs 52 A, 52 B advance the catheter adapter 18 and catheter 21 (not shown in FIG. 4 ) distally relative to housing 12
- the system 60 as shown in FIG. 4 includes a pair of stabilizing wings 62 A, 62 B extending from opposing sides of the housing 12 to form a stabilizing platform for the catheter adapter, with the stabilizing wings 62 A, 62 B incorporating respective gripping surfaces 64 A, 64 B thereon.
- One or both of the gripping surfaces 64 A, 64 B may be gripped by the clinician to advance the catheter adapter 18 and catheter 21 distally along the housing 12 .
- gripping surfaces 64 A, 64 B are shown as upwardly curved surfaces on the stabilizing wings 62 A, 62 B, it is to be understood that other shapes and/or configurations of gripping surfaces may be utilized on the stabilizing wings 62 A, 62 B.
- two gripping surfaces 64 A, 64 B are shown in FIG. 4 , it is to be understood that only one gripping surface may be provided.
- system 70 includes many similar features as system 10 described above with respect to FIGS. 1 and 2 and, as such, like reference numerals are used throughout.
- system 70 includes a near patient access port 72 configured for high-pressure injection.
- near patient access port 72 is configured to provide catheter access to peripheral devices such as, e.g., a blood draw device (e.g., PIVOTM from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements.
- peripheral devices such as, e.g., a blood draw device (e.g., PIVOTM from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements.
- a blood draw device e.g., PIVOTM from Becton, Dickinson and Company
- Near patient access port 72 includes a connector portion 74 .
- connector portion 74 is configured to be compatible with peripheral devices such as blood draw devices and/or vascular access probes.
- the connector portion 74 may include an interface for secure coupling of the peripheral device(s) to the connector portion 74 .
- the connector portion 74 is configured as a needle-free connector (NFC) configured to receive, e.g., a blunt introducer of a blood draw device. More specifically, the connector portion 74 may be configured as a split-septum NFC with direct probe access such as, e.g., Q-SyteTM or SmartSiteTM NFCs from Becton, Dickinson and Co., or any other appropriate split-septum NFC.
- the connector portion 74 may be formed of a non-split-septum-type NFC.
- the near patient access port 72 may include anti-microbial and/or flush-promoting features.
- the near patient access port 72 may include one or more of an offset tubing port vortex-creating feature, a proximal flow-diverting feature, anti-microbial NFC lubricant, anti-microbial eluting surface coating(s) or insert(s), etc.
- Near patient access port 72 further includes a high pressure injection port 76 positioned near a distal end thereof.
- the high pressure injection port 76 includes a secondary branch 78 that is coupled to the integrated extension set 32 , with the integrated extension set 32 further being coupled to a proximal portion 36 at a proximal end thereof. In this way, the near patient access port 72 may receive a high pressure injection via the proximal portion 36 and integrated extension set 32 .
- the high pressure injection port 76 is configured as a y-adapter. Additionally and/or alternatively, in some embodiments, high pressure injection port 76 may be color-coded and/or include indicia indicative of maximum flow rate, catheter length, maximum pressure rating, etc.
- the catheter of the catheter of system 70 may include a reinforced catheter tip and/or fenestrations in the catheter tip. In this way, the catheter is capable of improved gravity and high-pressure flow rate.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Public Health (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Vascular Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
An integrated midline catheter system including a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter. The system also includes a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port includes a connector portion couplable to a peripheral probe device. Furthermore, the system includes a catheter insertion device, wherein the catheter insertion device is configured to enable distal movement of the catheter adapter and catheter so as to position the catheter within a patient's vasculature.
Description
- The present application claims priority to U.S. Provisional Application Ser. No. 63/338,684, entitled “Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes”, filed May 5, 2022, the entire disclosure of which is hereby incorporated by reference.
- The present disclosure generally relates to integrated midline catheter systems. More particularly, the integrated midline catheter systems may include catheter adapter stabilization and a near patient access port configured for blood draw, infusion, and/or insertion of digital probes into the patient's vasculature via the indwelling midline catheter.
- Midline catheters are generally used for parenteral nutrition, IV fluid replacement, and/or the administration of analgesics and antibiotics. Midline catheters are inserted at the bedside using sterile techniques and can remain in place for several weeks. The insertion (venipuncture) is performed above and below the antecubital fossa in the cephalic, basilica, or bronchial veins. The catheter may be of various lengths and gauges, with the tip of the catheter terminating below the axilla and proximal central veins.
- The potential advantages of a midline catheter are the reduced frequency of repeated venipunctures for labs/restarts, decreased incidence of catheter related infections, extended implant/indwell duration, improved clinical outcomes, patient satisfaction and associated cost savings. Placing the catheter tip in the larger diameter veins of the upper arm compared to smaller veins provides for improvements in drug delivery therapy and hemodilution. Midline catheters can also be used for infusing contrast media at higher flow rates that are typically done by other catheters such as, e.g., peripheral intravenous catheters (PIVCs).
- However, an advantage of vascular access devices such as PIVCs over midline catheters is the recent development of systems to aid in blood draw and/or in-vein digital measurements directly from an indwelling catheter of the vascular access device. For example, a blood draw device known as PIVO™ from Becton, Dickinson and Company, is configured as a single-use device which temporarily attaches to a PIVC to draw a blood sample. Using an existing peripheral intravenous line as a conduit to the vasculature, the PIVO™ device advances a flexible, internal probe or flow tube through the PIVC to (or beyond) the catheter tip to collect a blood sample. This flow tube is designed to extend beyond the suboptimal draw conditions around the indwelling line to reach vein locations where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted, and the device is removed from the PIVC and discarded. An example of one such blood draw device is shown and described in U.S. Pat. No. 10,300,247 B2, which is incorporated by reference herein in its entirety. Similarly, devices configured direct probes, wires, fibers, guidewires, sensors, etc. through the PIVC and into the patient's vasculature for in-vein digital measurements have also been developed. On the other hand, conventional midline catheter systems lack the access architecture needed for compatibility with such blood draw and/or in-vein digital measurement devices.
- Accordingly, the present disclosure generally relates to an integrated midline catheter system. In accordance with an aspect of the present disclosure, the system includes a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter. The system also includes a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port includes a connector portion couplable to a peripheral probe device. The system further includes a catheter insertion device, wherein the catheter insertion device is configured to enable distal movement of the catheter adapter and catheter so as to position the catheter within a patient's vasculature.
- In some embodiments, the near patient access port further includes a secondary port, and the secondary port is coupled to an integrated extension set.
- In some embodiments, the system further includes a proximal access port coupled to a proximal end portion of the integrated extension set.
- In some embodiments, the proximal access port is color-coded to provide a flow rate indication.
- In some embodiments, the proximal access port comprises indicia indicative of at least one of catheter length and catheter gauge.
- In some embodiments, the connector portion of the near patient access port is a needle-free connector.
- In some embodiments, the needle-free connector is a split septum needle-free connector.
- In some embodiments, the near patient access port further includes a high-pressure injection port.
- In some embodiments, the high-pressure injection port is color-coded to provide a flow rate indication.
- In some embodiments, the high-pressure injection port includes indicia indicative of at least one of catheter length and catheter gauge.
- In some embodiments, the stabilization platform includes a pair of stabilizing wings.
- In some embodiments, each of the stabilizing wings includes a gripping surface to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
- In some embodiments, the system includes a pair of catheter advancement tabs extending from the catheter adapter and configured to provide to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
- In some embodiments, the catheter advancement tabs are detachable from the catheter adapter.
- In some embodiments, the catheter insertion device further includes a housing, an introducer needle extending distally from the housing, and an actuator tab slidable along the housing to selectively advance a guidewire through the introducer needle, wherein the catheter is configured to selectively advance over the introducer needle and the guidewire.
- In some embodiments, the catheter insertion device is detachable from the catheter adapter after insertion of the catheter within the patient's vasculature.
- According to another aspect of the present disclosure, an integrated midline catheter system is disclosed. The catheter system includes a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter. The system also includes a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port comprises a connector portion couplable to a peripheral probe device.
- In some embodiments, the catheter is between 8 cm and 10 cm in length.
- In some embodiments, the near patient access port further includes a secondary port, and the secondary port is coupled to an integrated extension set.
- In some embodiments, the connector portion of the near patient access port is a needle-free connector.
- Further details and advantages of the invention will become clear upon reading the following detailed description in conjunction with the accompanying drawing figures, wherein like parts are designated with like reference numerals throughout.
-
FIG. 1 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with an aspect of the present disclosure; -
FIG. 2 is an isometric view of the integrated midline catheter, stabilization, and near patient access port ofFIG. 1 ; -
FIG. 3 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure; -
FIG. 4 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure; and -
FIG. 5 is an isometric view of an integrated midline catheter system with a catheter insertion device, stabilization, and a near patient access port in accordance with another aspect of the present disclosure. - The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.
- For the purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.
- In the present disclosure, the distal end of a component or of a device means the end furthest away from the hand of the user and the proximal end means the end closest to the hand of the user, when the component or device is in the use position, i.e., when the user is holding a catheter insertion device in preparation for or during use. Similarly, in this application, the terms “in the distal direction” and “distally” mean in the direction toward distal tip of the needle or catheter of the system, and the terms “in the proximal direction” and “proximally” mean in the direction opposite the direction of the distal tip of the needle or catheter.
- Embodiments of the present disclosure will primarily be described in the context of devices for use with integrated midline catheters. However, embodiments of the present disclosure equally extend to use with other catheter devices.
- Referring to
FIG. 1 , an integratedmidline catheter system 10 in accordance with an aspect of the present disclosure is illustrated. In a first configuration, thesystem 10 includes acatheter insertion device 11 having ahousing 12. Anintroducer needle 14 extends from a distal end of thehousing 12, with theintroducer needle 14 having adistal tip 15. Due to the length of theintroducer needle 14, a distal end portion of thehousing 12 may include a feature or surface to at least partially support an intermediate portion of theintroducer needle 14 during insertion, thereby reducing the flexibility of theintroducer needle 14 during insertion. - An
actuator tab 16 is positioned on a surface of thehousing 12, with theactuator tab 16 configured for substantially linear movement along aslot 17 formed in thehousing 12. While not shown inFIG. 1 , theactuator tab 16 may be operably coupled to a guidewire, with the guidewire being sized and configured to selectively pass through (and beyond) theintroducer needle 14 asactuator tab 16 is advanced distally along theslot 17 and, conversely, to retract through theintroducer needle 14 when theactuator tab 16 is retracted proximally by the clinician. The guidewire may include a blunt, atraumatic tip to substantially prevent vascular damage. In some embodiments, a polymer rod or tubing with an atraumatic tip may replace the guidewire. - Still referring to
FIG. 1 , and also toFIG. 2 ,system 10 further includes acatheter adapter 18 having a stabilization platform formed of opposing stabilizingwings FIG. 1 , thecatheter adapter 18 is disposed at least partially within thehousing 12 such that the stabilizingwings housing 12. Thecatheter adapter 18 is configured to move linearly along thehousing 12 in a distal direction such that a catheter 21 (shown inFIG. 2 ) may be selectively advanced over theintroducer needle 14 and into the patient's vasculature. Thecatheter 21 may be any appropriate length and gauge for use as a midline catheter. For example,catheter 21 may have a length between 8 cm and 10 cm, and may be one of 16 GA, 18 GA, 20 GA, or 22 GA. However, it is to be understood thatcatheter 21 is not limited to the above-referenced lengths and/or gauges. Additionally, thecatheter 21 may be formed of any appropriate material such as, e.g., polyurethane. Thecatheter 21 may have a reinforcedtip 25, which may be configured to substantially prevent the catheter tip from collapsing and/or aid in deployment and positioning of thecatheter 21. - Placement of the
catheter 21 into the patient's vasculature utilizing thesystem 10 will now be explained in accordance with an embodiment of the present disclosure. First, the clinician identifies the appropriate insertion site, and cleans and prepares the insertion site in accordance with institutional policy. The clinician then grips and advances the entirecatheter insertion device 11 to insert theintroducer needle 14 into an appropriate vein or other vascular access location of the patient. While not shown, the system may include magnetic needle guidance to ensure proper insertion of theintroducer needle 14. The magnetic needle guidance may be used in conjunction with ultrasound placement system and methods such as, e.g., the Cue Needle Tracking System from Becton, Dickinson and Co. With theintroducer needle 14 in place, the clinician may then advance theactuator tab 16 distally along theslot 17 such that a guidewire (now shown) operably coupled to theactuator tab 16 simultaneously advances through theintroducer needle 14, thereby providing an extended guided path for deployment of thecatheter 21. - Next, with the guidewire in an advanced position, the clinician may distally advance the
catheter adapter 18 along thehousing 12, thereby also advancing thecatheter 21 over theintroducer needle 14 and guidewire, moving thecatheter 21 into a desired position within the patient's vasculature. To distally advance thecatheter adapter 18, the clinician may grip or otherwise manipulate one or both of the stabilizingwings side branch 22 extending from thecatheter adapter 18 to aid in advancement of thecatheter adapter 18 andcatheter 21. - With the
catheter 21 andcatheter adapter 18 in a desired position, the clinician may separate thecatheter insertion device 11 from thecatheter adapter 18. In some embodiments, thehousing 12 of thecatheter insertion device 11 may at least partially split after placement of thecatheter 21, allowing thehousing 12 separate from thecatheter adapter 18. In doing so, theintroducer needle 14 and guidewire (not shown) are also withdrawn from thecatheter 21 and are pulled through a self-sealing proximal connector portion 19 of thecatheter adapter 18. Accordingly, with thecatheter insertion device 11 removed, thecatheter adapter 18 remains in place at the insertion site in the second configuration shown inFIG. 2 , with the stabilizingwings catheter adapter 18. In some embodiments, astrain relief feature 23 may be provided between thecatheter adapter 18 and thecatheter 21. - Referring still to
FIGS. 1 and 2 , thesystem 10 further includes a nearpatient access port 26. Nearpatient access port 26 is configured to provide catheter access to peripheral devices such as, e.g., a blood draw device (e.g., PIVO™ from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements. In some embodiments, the nearpatient access port 26 is coupled to theside branch 22 ofcatheter adapter 18 via a length ofintermediate tubing 24. However, in other embodiments, it is to be understood that nearpatient access port 26 may be coupled directly to theside branch 22, or connected via another intermediate member. - Near
patient access port 26 includes aconnector portion 28. In some embodiments,connector portion 28 is configured to be compatible with peripheral devices such as blood draw devices and/or vascular access probes. Theconnector portion 28 may include an interface for secure coupling of the peripheral device(s) to theconnector portion 28. In some embodiments, theconnector portion 28 is configured as a needle-free connector (NFC) configured to receive, e.g., a blunt introducer of a blood draw device. More specifically, theconnector portion 28 may be configured as a split-septum NFC with direct probe access such as, e.g., Q-Syte™ or SmartSite™ NFCs from Becton, Dickinson and Co., or any other appropriate split-septum NFC. Alternatively, in other embodiments, theconnector portion 28 may be formed of a non-split-septum-type NFC. Furthermore, in some embodiments, the nearpatient access port 26 may include anti-microbial and/or flush-promoting features. For example, the nearpatient access port 26 may include one or more of an offset tubing port vortex-creating feature, a proximal flow-diverting feature, anti-microbial NFC lubricant, anti-microbial eluting surface coating(s) or insert(s), etc. - With near
patient access port 26 fluidly coupled to thecatheter adapter 18 via theside port 22, thesystem 10 provides for probe (or tube) access from a peripheral probe device through theindwelling catheter 21. Ascatheter 21 is a midline catheter and is generally longer in length than, e.g., a PIVC, the length probe or tube of the peripheral probe device may be altered and/or optimized for use with the midline catheter, thereby enabling the probe or tube to potentially extend beyond the reinforcedtip 25 of thecatheter 21 when deployed. - Near
patient access port 26 further includes asecondary port 30 positioned near a distal end thereof. In some embodiments, thesecondary port 30 is coupled to an integrated extension set 32, with the integrated extension set 32 further being coupled to aproximal portion 36 at a proximal end thereof. Aclamp 34 may be provided on the integrated extension set 32, with theclamp 34 configured to selectively restrict flow through the integrated extension set 32. In some embodiments, theclamp 34 may be color-coded to signify the type and/or injection compatibility of the integrated extension set 32. - In some embodiments, the
proximal portion 36 may include aproximal access port 38 and aproximal connector 40. Theproximal connector 40 may be removably or non-removably coupled to theproximal access port 38, andproximal connector 40 may be configured to allow fluid infusion through thecatheter 21 via the nearpatient access port 26. In some embodiments, theproximal access port 38 may be color-coded and/or may contain indicia to indicate catheter length, catheter gauge, high-pressure injection compatibility, etc. In other embodiments, during insertion of thecatheter 21 into the patient's vasculature, theproximal connector 40 may be replaced with, e.g., a removable vent plug. In some embodiments, theproximal access port 38 may be a non-split-septum connector, and may include antimicrobial and/or flush-ability features. While only a singleproximal access port 38 is shown, it is to be understood that theproximal portion 36 may be configured to include more than one access port. - In the embodiments shown in
FIGS. 1 and 2 , thesecondary port 30 of the nearpatient access port 26 is configured as an angled port, resulting in the nearpatient access port 26 being a y-shaped adapter. However, in other embodiments, thesecondary port 30 may be configured as a t-shaped adapter such that thesecondary port 30 enters the nearpatient access port 26 at a substantially 90° angle. Additionally, whilesecondary port 30 is shown as being directed towards the center of the device, it is to be understood thatsecondary port 30 may be directed away from the device. - Accordingly, the integrated
midline catheter system 10 described above with respect toFIGS. 1 and 2 provides a midline catheter system with a near patient access port compatible with instrument, probe, and/or tubing delivery through the midline catheter and into the patient's vascular system, which conventional integrated midline catheter systems do not provide. - Referring now to
FIG. 3 , an integratedmidline catheter system 50 in accordance with another aspect of the present disclosure is shown.System 50 includes many similar features assystem 10 described above with respect toFIGS. 1 and 2 and, as such, like reference numerals are used throughout. However, unlikesystem 10, which utilized only stabilizingwings side branch 22 of thecatheter adapter 18 to advance thecatheter adapter 18 andcatheter 21 distally relative tohousing 12, the catheter insertion device 51 as shown inFIG. 3 includes a pair ofcatheter advancement tabs 52A, 52B extending from opposing sides of thehousing 12, with thecatheter advancement tabs 52A, 52B being separate from the stabilizingwings - The
catheter advancement tabs 52A, 52B are operably coupled to the catheter adapter 18 (not shown inFIG. 3 ) so as to provide grips for the clinician to advance thecatheter adapter 18 andcatheter 21 distally along thehousing 12. In some embodiments, when the clinician retracts and decouples the catheter insertion device 51 after the catheter is in place within the patient's vasculature, thecatheter advancement tabs 52A, 52B remain in place with thecatheter adapter 18. In some embodiments, thecatheter advancement tabs 52A, 52B may be separable and removable from thecatheter adapter 18 after placement of the catheter. Additionally and/or alternatively, in some embodiments, thecatheter advancement tabs 52A, 52B may be color-coded according to the length and/or gauge of the catheter housed within the catheter insertion device 51. Furthermore, while twocatheter advancement tabs 52A, 52B are shown inFIG. 3 , it is to be understood that only one catheter advancement tab may be provided. - Next, referring to
FIG. 4 , an integratedmidline catheter system 60 in accordance with another aspect of the present disclosure is shown. Again,system 60 includes many similar features assystem 10 described above with respect toFIGS. 1 and 2 and, as such, like reference numerals are used throughout. However, unlikesystem 50, which utilized separatecatheter advancement tabs 52A, 52B advance thecatheter adapter 18 and catheter 21 (not shown inFIG. 4 ) distally relative tohousing 12, thesystem 60 as shown inFIG. 4 includes a pair of stabilizing wings 62A, 62B extending from opposing sides of thehousing 12 to form a stabilizing platform for the catheter adapter, with the stabilizing wings 62A, 62B incorporating respectivegripping surfaces 64A, 64B thereon. One or both of thegripping surfaces 64A, 64B may be gripped by the clinician to advance thecatheter adapter 18 andcatheter 21 distally along thehousing 12. - In some embodiments, when the clinician retracts and decouples the
catheter insertion device 61 after the catheter is in place within the patient's vasculature, and the stabilizing wings 62A, 62B withgripping surfaces 64A, 64B remain in place with thecatheter adapter 18. While grippingsurfaces 64A, 64B are shown as upwardly curved surfaces on the stabilizing wings 62A, 62B, it is to be understood that other shapes and/or configurations of gripping surfaces may be utilized on the stabilizing wings 62A, 62B. Furthermore, while twogripping surfaces 64A, 64B are shown inFIG. 4 , it is to be understood that only one gripping surface may be provided. - Referring now to
FIG. 5 , an integratedmidline catheter system 70 in accordance with another aspect of the present disclosure is shown. As withsystems system 70 includes many similar features assystem 10 described above with respect toFIGS. 1 and 2 and, as such, like reference numerals are used throughout. However,system 70 includes a nearpatient access port 72 configured for high-pressure injection. Additionally, nearpatient access port 72 is configured to provide catheter access to peripheral devices such as, e.g., a blood draw device (e.g., PIVO™ from Becton, Dickinson and Company), or a vascular access probe (VAP) for in-vein digital measurement of patient date such as temperature, pH, lactate, and/or other blood-based measurements. - Near
patient access port 72 includes aconnector portion 74. In some embodiments,connector portion 74 is configured to be compatible with peripheral devices such as blood draw devices and/or vascular access probes. Theconnector portion 74 may include an interface for secure coupling of the peripheral device(s) to theconnector portion 74. In some embodiments, theconnector portion 74 is configured as a needle-free connector (NFC) configured to receive, e.g., a blunt introducer of a blood draw device. More specifically, theconnector portion 74 may be configured as a split-septum NFC with direct probe access such as, e.g., Q-Syte™ or SmartSite™ NFCs from Becton, Dickinson and Co., or any other appropriate split-septum NFC. Alternatively, in other embodiments, theconnector portion 74 may be formed of a non-split-septum-type NFC. Furthermore, in some embodiments, the nearpatient access port 72 may include anti-microbial and/or flush-promoting features. For example, the nearpatient access port 72 may include one or more of an offset tubing port vortex-creating feature, a proximal flow-diverting feature, anti-microbial NFC lubricant, anti-microbial eluting surface coating(s) or insert(s), etc. - Near
patient access port 72 further includes a highpressure injection port 76 positioned near a distal end thereof. In some embodiments, the highpressure injection port 76 includes asecondary branch 78 that is coupled to the integrated extension set 32, with the integrated extension set 32 further being coupled to aproximal portion 36 at a proximal end thereof. In this way, the nearpatient access port 72 may receive a high pressure injection via theproximal portion 36 and integrated extension set 32. - In some embodiments, the high
pressure injection port 76 is configured as a y-adapter. Additionally and/or alternatively, in some embodiments, highpressure injection port 76 may be color-coded and/or include indicia indicative of maximum flow rate, catheter length, maximum pressure rating, etc. - Furthermore, while not shown in
FIG. 5 , the catheter of the catheter ofsystem 70 may include a reinforced catheter tip and/or fenestrations in the catheter tip. In this way, the catheter is capable of improved gravity and high-pressure flow rate. - While several embodiments of integrated midline catheter systems having near patient access ports for peripheral probe device access were described in the foregoing detailed description, those skilled in the art may make modifications and alterations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are embraced within their scope.
Claims (20)
1. An integrated midline catheter system comprising:
a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter;
a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port comprises a connector portion couplable to a peripheral probe device; and
a catheter insertion device, wherein the catheter insertion device is configured to enable distal movement of the catheter adapter and catheter so as to position the catheter within a patient's vasculature.
2. The system of claim 1 , wherein the near patient access port further comprises a secondary port, and wherein the secondary port is coupled to an integrated extension set.
3. The system of claim 2 , further comprising a proximal access port coupled to a proximal end portion of the integrated extension set.
4. The system of claim 3 , wherein the proximal access port is color-coded to provide a flow rate indication.
5. The system of claim 3 , wherein the proximal access port comprises indicia indicative of at least one of catheter length and catheter gauge.
6. The system of claim 1 , wherein the connector portion of the near patient access port is a needle-free connector.
7. The system of claim 6 , wherein the needle-free connector is a split septum needle-free connector.
8. The system of claim 1 , wherein the near patient access port further comprises a high-pressure injection port.
9. The system of claim 8 , wherein the high-pressure injection port is color-coded to provide a flow rate indication.
10. The system of claim 8 , wherein the high-pressure injection port includes indicia indicative of at least one of catheter length and catheter gauge.
11. The system of claim 1 , wherein the stabilization platform comprises a pair of stabilizing wings.
12. The system of claim 11 , wherein each of the stabilizing wings comprises a gripping surface to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
13. The system of claim 1 , further comprising a pair of catheter advancement tabs extending from the catheter adapter and configured to provide to provide a grip for the distal movement of the catheter adapter and catheter along the catheter insertion device.
14. The system of claim 13 , wherein the catheter advancement tabs are detachable from the catheter adapter.
15. The system of claim 1 , wherein the catheter insertion device further comprises a housing, an introducer needle extending distally from the housing, and an actuator tab slidable along the housing to selectively advance a guidewire through the introducer needle, wherein the catheter is configured to selectively advance over the introducer needle and the guidewire.
16. The system of claim 1 , wherein the catheter insertion device is detachable from the catheter adapter after insertion of the catheter within the patient's vasculature.
17. An integrated midline catheter system comprising:
a catheter adapter having a catheter extending therefrom, a stabilization platform, a proximal connector portion fluidly coupled to the catheter, and a side branch fluidly coupled to the catheter; and
a near patient access port coupled to the side branch of the catheter adapter, wherein the near patient access port comprises a connector portion couplable to a peripheral probe device.
18. The system of claim 17 , wherein the catheter is between 8 cm and 10 cm in length.
19. The system of claim 17 , wherein the near patient access port further comprises a secondary port, and wherein the secondary port is coupled to an integrated extension set.
20. The system of claim 17 , wherein the connector portion of the near patient access port is a needle-free connector.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18/143,318 US20230355943A1 (en) | 2022-05-05 | 2023-05-04 | Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202263338684P | 2022-05-05 | 2022-05-05 | |
US18/143,318 US20230355943A1 (en) | 2022-05-05 | 2023-05-04 | Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes |
Publications (1)
Publication Number | Publication Date |
---|---|
US20230355943A1 true US20230355943A1 (en) | 2023-11-09 |
Family
ID=88566223
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US18/143,318 Pending US20230355943A1 (en) | 2022-05-05 | 2023-05-04 | Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes |
Country Status (3)
Country | Link |
---|---|
US (1) | US20230355943A1 (en) |
CN (2) | CN220046784U (en) |
WO (1) | WO2023215445A1 (en) |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6638252B2 (en) * | 2001-05-25 | 2003-10-28 | Becton Dickinson And Company | Cantilever push tab for an intravenous medical device |
US7198620B2 (en) * | 2003-11-13 | 2007-04-03 | The United States Of America As Represented By The Secretary Of The Army | One stage saline lock and intravenous catheter set and method of use |
US10265506B2 (en) * | 2015-02-02 | 2019-04-23 | Quick Snap Medical Supply, LLC | Vascular access devices and methods |
US10806901B2 (en) * | 2015-10-28 | 2020-10-20 | Becton, Dickinson And Company | Catheter adapter with distal inner diameter curvature providing kink resistance |
CA3015157A1 (en) * | 2016-02-18 | 2017-08-24 | Smiths Medical Asd, Inc. | Closed system catheter |
US11291803B2 (en) * | 2018-01-11 | 2022-04-05 | Becton, Dickinson And Company | Catheter system with guidewire advancement element |
US11648385B2 (en) * | 2019-05-30 | 2023-05-16 | Beeton, Dickinson and Company | Automatic disinfection of a vascular access device connector |
-
2023
- 2023-05-04 US US18/143,318 patent/US20230355943A1/en active Pending
- 2023-05-04 WO PCT/US2023/020948 patent/WO2023215445A1/en unknown
- 2023-05-05 CN CN202321060638.5U patent/CN220046784U/en active Active
- 2023-05-05 CN CN202310507384.5A patent/CN116999676A/en active Pending
Also Published As
Publication number | Publication date |
---|---|
CN220046784U (en) | 2023-11-21 |
CN116999676A (en) | 2023-11-07 |
WO2023215445A1 (en) | 2023-11-09 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN211798162U (en) | Catheter assembly | |
CN116269373A (en) | Peripheral intravenous catheter assembly with extension kit | |
JP2023507642A (en) | CATHETER EXTENSION SET AND ASSOCIATED METHOD | |
US20240066270A1 (en) | Integrated Catheter System with Multiple Extension Sets | |
US20230355943A1 (en) | Full Featured Integrated Midline Catheter System with Stabilization and Near Patient Access Port Blood Draw, Infusion, and Digital Probes | |
JP2023517087A (en) | Instrument delivery device, system and method for extending through a thrombus | |
US20240066269A1 (en) | Integrated Midline Catheter System | |
US20230372675A1 (en) | Vascular Access System With Integrated Catheter, Extension Set Providing Integrated Catheter Septum Access, Stabilization Features and Direct Probe Access | |
CN221357963U (en) | Integrated catheter system | |
US20230233803A1 (en) | Systems and Methods for Adjusting the Length of Line Draw Lever Lock Components for Compatibility With Various Length Peripheral Intravenous Catheters (PIVC) | |
US20230001145A1 (en) | Non-Integrated Catheter System Having an Extension Set | |
CN220256467U (en) | Vascular access system and blood collection device | |
US20240238572A1 (en) | Vascular Access Device with Over-the-Catheter Introducer Needle and Near Patient Access Port | |
CN221490987U (en) | Catheter assembly | |
US20240269432A1 (en) | Blood Draw Connector for Open Peripheral Intravenous Catheters | |
US20230329605A1 (en) | Blood Draw Device with Catheter Length Adjustable Advancement Stop and Tube Position Indicator | |
US20240016428A1 (en) | Integrated Catheter System with Near Patient Access Port and Visual Indicators | |
CN220459760U (en) | Integrated intravenous catheter system and needleless connector | |
US20230166086A1 (en) | Integrated Catheter with Stabilized Near-Patient Port Extension Set Architecture | |
US20240057909A1 (en) | A Blood Collection Device with Improved Blood Draw Time | |
US20140275909A1 (en) | Catheter and sheath introducer |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BECTON, DICKINSON AND COMPANY, NEW JERSEY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BURKHOLZ, JONATHAN KARL;REEL/FRAME:063538/0954 Effective date: 20220614 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |